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Not yet recruitingPhase 4

Immediate Versus Criterion-triggered Semaglutide for Suboptimal Clinical Response One Year After Primary Metabolic and Bariatric Surgery

Immediate Versus Criterion-triggered Semaglutide for Suboptimal Clinical Response One Year After Primary Metabolic and Bariatric Surgery: a Randomized, Double-blind Strategy Trial

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

-

Estimated enrollment

100

Study population

Obesity / overweight

Eligibility highlights

-

Primary endpoint

•Percentage total weight loss

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07859189
Org study IDTOP-UP Trial

Timeline

Milestones

Study first posted2026-10-05actual
Last update posted2026-10-05actual
Study start2026-10estimated (month precision)
Primary completion2028-10estimated (month precision)
Study completion2028-10estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Primary laparoscopic SG or RYGB at our unit or a participating unit
•%TWL less than 20% from the day of surgery, in one of two tiers. Tier A, surgical nonresponse: below 10% TWL at the 12-month visit; eligible immediately, randomization between months 12 and 14. Tier B, suboptimal response: 10 to below 20% TWL at the 12-month visit; eligible only after a documented plateau, randomization between months 12 and 18 (Plateau, defined. Two clinic weights at least 12 weeks apart differing by less than 2% of body weight, on the trial scale, with no change in treatment between them. This sits inside the swing the consensus panel itself called normal physiologic fluctuation. A Tier B patient still losing at month 12 is re-weighed at months 15 and 18. Reaching 20% TWL at any point means a good response and no enrollment. Still below 20% at month 18 means eligible regardless of plateau; the cap stops watchful waiting from becoming neglect.)
•Anatomy assessed as normal in all: upper endoscopy for every patient, contrast study when symptoms suggest it
•Able to self-inject and consent.

Exclusion criteria

•Any GLP-1-based therapy since surgery
•Recurrent weight gain by the consensus definition, regain of more than 25% of the weight lost from nadir; these patients belong to RESURGE, not here
•Anatomical abnormality explaining the poor response (these patients go to the revision pathway, not this trial)
•Pregnancy or conception planned within the study (obesity pharmacotherapy is stopped at least 2 months before any planned conception, per current labeling and the 2026 Standards)
•type 1 diabetes
•medullary thyroid carcinoma or MEN2 history
•pancreatitis history
•untreated severe depression or active eating disorder on psychological review

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
2
Cardiometabolic biomarkers
2
Other (unclassified)
2
Glycemic / diabetes
1

Weight & body composition

2 endpoints
Primary/protocol endpoint

Percentage total weight loss

Time frame:at 12 months

descriptive

Secondary/protocol endpoint

Percentage total weight loss

Time frame:6, 24 months

descriptive

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

change in HbA1c

Time frame:12, 24 months

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

systolic and diastolic blood pressure

Time frame:12, 24 months

descriptive

Secondary/protocol endpoint

total cholesterol, LDL, HDL, and triglycerides

Time frame:12, 24 months

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Hand-grip strength

Time frame:0, 12, 24 months

descriptive

Secondary/protocol endpoint/low confidence

change in IWQOL-Lite-CT total and domain scores

Time frame:0, 12, 24 months

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.